# FDA 483 - Invitrx Therapeutics - September 18, 2019

Source: https://www.globalkeysolutions.net/records/483/invitrx-therapeutics/66d487b8-f7d1-409b-ac28-edfa0caf9c14

> FDA 483 for Invitrx Therapeutics on September 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Invitrx Therapeutics
- Inspection Date: 2019-09-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Invitrx Therapeutics in San Juan, PR, from September 13-18, 2019, revealed multiple significant deficiencies in their manufacturing of umbilical cord blood products. Key issues included inadequate environmental monitoring, lack of validated aseptic processes, insufficient employee training, and incomplete batch production records. These observations indicate a failure to maintain proper control over critical manufacturing operations, potentially impacting product quality and sterility.

## Related Officers

- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)
- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/invitrx-therapeutics/ea81a6db-5722-4d62-b932-8953556f35a9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6